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K Number
K972070
Device Name
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
Manufacturer
NICHOLS INSTITUTE DIAGNOSTICS
Date Cleared
1997-06-26

(23 days)

Product Code
JJY
Regulation Number
862.1660
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Nichols Advantage Chemiluminescence Tri-Level Specialty Controls is intended for use an assayed quality control serum to monitor the accuracy and precision of the Nichols Advantage immunoassays

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device: "Nichols Advantage Chemiluminescence Tri-Level Specialty Controls." This document primarily grants clearance based on substantial equivalence and does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving those criteria were met.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

This indicates that the device was deemed substantially equivalent to a predicate device, meaning a comprehensive study with specific acceptance criteria, sample sizes, expert ground truth, and adjudication methods, as typically understood for a new algorithm or AI-based device, is not presented in this document. The focus here is on regulatory clearance based on equivalence rather than detailed performance study results.

Therefore, I cannot provide details for the following questions based on the given text:

  1. A table of acceptance criteria and the reported device performance: Not available.
  2. Sample sized used for the test set and the data provenance: Not available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available (device is a quality control serum, not an AI diagnostic tool).
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available (device is a quality control serum, not an algorithm).
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
  8. The sample size for the training set: Not available.
  9. How the ground truth for the training set was established: Not available.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.